Kornimate/medical-research-clean huggingface dataset:
investigating the effects of the "gameday ready" behavioral weight management program for black men living in the rural south

Conditions: Obesity

Summary: this pilot study investigates the effects of a newly developed 12-week weight management program called "gameday ready" (compared to a walking and general health education program) for decreasing body weight among black men who live in the rural south. the researchers expect to see evidence of greater weight loss among participants randomized to receive the "gameday ready" program.


Eligibility criteria:
inclusion criteria: * self-identified african american or black american male * 25-65 years of age * bmi 27kg/m2 to ≤50kg/m2 (those with a bmi \>45 will need documented approval by a healthcare provider to participate in the study) * live in a rural area of south carolina and have lived in a rural area for at least 1 year * able to speak and understand english * willing to be randomized to the intervention or comparison program exclusion criteria: * positive response to any question on the physical activity readiness questionnaire (par-q) (participant may be included if approval is provided and documented by a healthcare provider) * currently participating in another weight loss trial or program or have participated in a trial or program within 6 months prior to starting the intervention * uncontrolled hypertension (systolic blood pressure ≥160 mm hg or diastolic blood pressure ≥100 mm hg), diabetes, or asthma (participant may be included if approval is provided and documented by a healthcare provider) * pulmonary disease requiring supplemental oxygen or daily use of short-acting bronchodilators * any musculoskeletal condition that would preclude meeting recommended levels of moderate-to- vigorous physical activity * within 30 days prior to participating in the study, have taken prescription or nonprescription medications, herbals, or supplements for weight loss * on special diet for a serious health condition (does not include general dietary advice from a healthcare provider for common risk factors such as hypertension, diabetes, or hyperlipidemia). * major surgery in the past 6 months * have undergone weight loss surgery or considering weight loss surgery within the next 6 months * have been treated for cancer in the past 12 months (other than non-melanoma skin cancer) * weight loss ≥5% during the past 6 months * plans to move to another county in the next 6 months * any other perceived physical or mental health-related condition that would preclude participating in a behavioral program designed to promote weight loss
app-technology to improve healthy lifestyle behaviors among working adults

Conditions: Lifestyle; Quality of Life; mHealth; Mobile Applications; Adults

Summary: the aim of this study is to evaluate if modern technology such as smartphone applications can be used to facilitate lifestyle changes and thereby improve health-related quality of life in gainfully employed persons in the general population in stockholm, sweden. the hypothesis is that at follow-up, the intervention group that use the new application will have improved health-related quality of life and other lifestyle habits including diet, physical activity and sleep, as well as biomarkers, compared to a control group.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * ability to communicate in swedish * have access to and use a smartphone exclusion criteria: -
quantitative evaluation of the impact of relaxing eligibility criteria for lung cancer based on real-world data

Conditions: Lung Cancer

Summary: eligibility criteria for cancer drug trials are generally too stringent, leading to key issues such as low enrolment rates and lack of population diversity. in order to evaluate the rec of nsclc drug trials, this study will use deep learning methods to construct a structured real-world database of nsclc across dimensions, and quantitatively assess the independent contribution of changes in each eligibility criterion to patient numbers, clinical efficacy and safety.

restrictive eligibility criteria in cancer drug trials result in low enrollment rates and limited population diversity. relaxed eligibility criteria (rec) based on solid evidence is becoming necessary for stakeholders worldwide. however, the absence of high-quality, favorable evidence remains a major challenge. this study presents a protocol to quantitatively evaluate the impact of relaxing eligibility criteria in common non-small cell lung cancer (nsclc) protocols in china, on the risk-benefit profile. this involves a detailed explanation of the rationale, framework, and design of rec. to evaluate our rec in nsclc drug trials, we will first construct a structured, cross-dimensional real-world nsclc database using deep learning methods. we will then establish randomized virtual cohorts and perform benefit-risk assessment using monte carlo simulation and propensity matching. shapley value will be utilized to quantitatively measure the effect of the change of each eligibility criterion on patient volume, clinical efficacy and safety.

Eligibility criteria:
inclusion criteria: patients in the database were considered to be part of the real-world cohort if they were (1) diagnosed with nsclc according to the tenth revision of the international classification of diseases (icd-10) code; (2) diagnosed with stage iiib, iiic, iv nsclc between 1 january 2013 and 31 december, 2022; (3) had at least two documented clinical visits on or after 1 january 2013. exclusion criteria: （1）nsclc in stage i-iiia
brain health in midlife

Conditions: Brain Health; Gestational Hypertension; Alzheimer Disease; Dementia; Cardiovascular Diseases; Pregnancy Related; Pre-Eclampsia

Summary: the purpose of this study is to learn if hypertensive disorders during pregnancy affects brain health in midlife.


Eligibility criteria:
inclusion criteria: * participated in the adore trial ( r01 hd083292) exclusion criteria: * history of seizures or epilepsy * pregnant at screening * ineligible to complete mri due to metal in the body
comparison between interscalene block and combined suprascapular and axillary blocks for proximal humerus fracture surgeries.

Conditions: Proximal Humerus Fractures

Summary: a comparative study between ultrasound guided interscalene block and combined ultrasound guided suprascapular and axillary nerve blocks for proximal humerus fracture surgeries. the aim of this study is to investigate whether (suprascapular nerve block) and (axillary nerve block) are effective in providing analgesia for shoulder surgery as an (interscalene block), while minimizing the occurrence of hemi-diaphragmatic paralysis. we hypothesized that analgesia with a (suprascapular nerve block and axillary nerve block) would be noninferior compared with patients receiving an interscalene block and the incidence of hemi-diaphragmatic paralysis would be significantly lower with (suprascapular nerve block and axillary nerve block) in proximal humerus fracture surgeries.

a comparative study between ultrasound guided interscalene block and combined ultrasound guided suprascapular and axillary nerve blocks for proximal humerus fracture surgeries. the aim of this study is to investigate whether (suprascapular nerve block) and (axillary nerve block) are effective in providing analgesia for shoulder surgery as an (interscalene block), while minimizing the occurrence of hemi-diaphragmatic paralysis. we hypothesized that analgesia with a (suprascapular nerve block and axillary nerve block) would be noninferior compared with patients receiving an interscalene block and the incidence of hemi-diaphragmatic paralysis would be significantly lower with (suprascapular nerve block and axillary nerve block) in proximal humerus fracture surgeries.

Eligibility criteria:
inclusion criteria: 1. patients american society of anesthesiologists' physical status (asa) i to ii. 2. aged 18 to 65 years. 3. both sexes. 4. patients scheduled for proximal humerus fracture surgeries. exclusion criteria: 1. patient refusal 2. asa physical status iii or more. 3. patients with known allergy to any of the study drugs. 4. infection at the site of injection. 5. patients with history of cardiovascular disease. 6. patients with renal disease. 7. patients with hepatic disease. 8. patients with neuromuscular disease. 9. presence of any coagulopathy. 10. chronic opioid, gabapentin or pregabalin use. 11. patients with history of any psychiatric disorder. 12. bmi more than 35 kg/m2.
study of [s,s]-reboxetine in patients with postherpetic neuralgia, who are gabapentin treatment failures

Conditions: Pain

Summary: the purpose of this study is to determine the effectiveness of \[s,s\]-reboxetine in the treatment of chronic pain following a shingles infection in patients who are gabapentin treatment failures.


Eligibility criteria:
inclusion criteria: * patients must have pain present for more than 3 months after the healing of shingles skin rash. * patients at screening must have a score \> or = 40 mm on the pain visual analogue scale. exclusion criteria: * patients with poor renal function. * patients with other severe pain, that may impair the self-assessment of the pain due to shingles. * patients with abnormal electrocardiogram.
amniotic membrane treatment for hyposecretory dry eye

Conditions: Dry Eye Syndromes; Sjogren Syndrome With Keratoconjunctivitis

Summary: the goal of this randomized, active-controlled, parallel-group trial is to evaluate the clinical efficacy of amniotic membrane extract eye drops (ameed) in reducing signs and symptoms of hyposecretory dry eye participants will receibed amniotic membrane extract eye drops 6 times daily and was evaluated at baseline day and day 30th. researchers will compare against autologous serum eye drops effects

this was a randomized, active-controlled, parallel-group trial. the perfect masked conditions could not be accomplished because the autologous serum eye drops needs venous punction for it preparation. during de initial 2 weeks screening period, the patients received artificial tears 4 times daily to minimize the effects of any eye drops used before patients were allocated randomly to receive autologous serum eye drops (ased) or ameed, administered as 1 drop in each eye 6 times daily, respectively, for 30 days.

Eligibility criteria:
inclusion criteria: * 21 years of age or older * dry eye related symptoms * fluorescein corneal staining score of 4 or more * lisamina green conjunctival score of 4 or more * a no-anesthesia schirmer test value at 5' of 10 mm or less exclusion criteria: * glaucoma treatment * surgical procedures within 3 months of the baseline evaluation * precense of punctal plug * patients that were human immunodeficiency virus positive

Keywords: dry eye autologous serum amniotic membrane extract eye drops
a pilot study of oral tinidazole for women with recurrent bacterial vaginosis

Conditions: Recurrent Bacterial Vaginosis

Summary: this is a study of the drug tinidazole for women with recurrent bacterial vaginosis. half of the participants will get the drug for 10 days, the other half will get the drug for 10 days and then twice a week for 12 weeks.

this study will recruit 60 women with recurrent bacterial vaginosis. these women must have a current infection to be enrolled in the study and have had two other infections within the past 12 months. after initial screening to make sure that the vaginal symptoms are due to bacterial vaginosis and not the results of a different infection, all of the women will receive tinidazole (a drug that is similar to metronidazole) by mouth for 10 days. at the end of the 10 days, patients will be re-examined. those women who are free of bacterial vaginosis will enter the second phase of the study, where half of the patients will continue to take tinidazole twice a week for twelve weeks and the other half will take no medication. during this time participants will be examined by the study doctor every 4 weeks to see how effective the treatment has been at preventing the recurrence of bacterial vaginosis. at the end of the 12 weeks, women who are still free of bacterial vaginosis will be seen for 3 more visits over 3 months.

Eligibility criteria:
inclusion criteria: * current infection with bacterial vaginosis * 2 previous episodes of bacterial vaginosis within the past 12 months * willing to use contraception * able to swallow pills * willing to refrain from douching or using vaginal products * willing to refrain from alcohol consumption 24 hours before and for 72 hours after taking study medication (tinidazole) exclusion criteria: * women with same sex partners * menstruating at initial exam * presence of yeast, a sexually transmitted disease, or other vaginal infection * purulent cervical discharge * use of any drug for bacterial vaginosis or yeast within the past 2 weeks prior to enrollment * pregnant or nursing * taking lithium * taking blood thinners (anticoagulation therapy) * use of any investigational drug within the previous 30 days * active hpv infection requiring treatment * use of drugs that suppress the immune system * history of alcoholism * taking disulfiram

Keywords: bacterial vaginosis tinidazole vaginitis
diagnosis of depression among adolescents

Conditions: Depression

Summary: the objective of the study is to improve general practitioners' diagnoses of adolescent depression. major depression is ranked fourth in the worldwide disability impact. the proportion of adolescents suffering from depressive disorders also seems to be increasing worldwide. early interventions are known to reduce this illness. therefore, the earlier depression can be identified in adolescents, the greater the advantage.


Eligibility criteria:
inclusion criteria: * age (14-16) exclusion criteria: * not fluency in the norwegian and danish language

Keywords: depression validation adolescent validation of three key questions and questionnaire
study of arixtra (fondaparinux sodium) to prevent blood clots in women undergoing abdominopelvic surgery for likely gynecologic malignancy

Conditions: Venous Thrombosis

Summary: this is a randomized trial to compare intermittent compression devices with or without post-operative arixtra (fondaparinux sodium) in women undergoing major abdominal surgery for known or presumed gynecologic malignancies. this trial seeks to determine if there is a difference in the rate of deep venous thrombosis between these two groups.

to assess the effectiveness of arixtra (fondaparinux sodium) in the prophylaxis of deep venous thromboembolism in gynecologic oncology patients undergoing abdominopelvic surgery.

Eligibility criteria:
inclusion criteria: * all patients undergoing open laparotomy (non-laparoscopic) gynecologic surgery. * patients must be competent to self-administer injections, or must have caregivers or nurses who can perform injections * patients must have signed an approved informed consent exclusion criteria: * patients with medical history which requires chronic anticoagulation (i.e. previous dvt, pulmonary embolism, atrial fibrillation, heart valve replacement) * patients with contraindications to anticoagulation (generalized bleeding disorders, peptic ulcer disease, hemorrhagic stroke, etc) * contraindications to placement of icds (history of lower extremity venous stasis ulcers) * patients receiving low molecular weight heparin or unfractionated heparin for prophylaxis post-operatively * patients who are unable to receive injections as an outpatient and/or unable to undergo a doppler ultrasound of the lower extremities * renal insufficiency (creatinine clearance \< 30 ml/min) * patients who have a body weight \< 50 kg * hypersensitivity to low molecular weight heparin * patients who are pregnant or have a positive pregnancy test. * patients receiving continuous (indwelling) epidural.

Keywords: randomized clinical trials randomized controlled trial venous thrombosis anticoagulant drugs doppler ultrasound postoperative complications
plasma, urine and tear omics changes in different diets

Conditions: Diet, Healthy

Summary: the study plans to start in july 2021, and it is expected that 20 healthy people (aged 18-70 years old, bmi 18.5-40kg/m2) will carry out a 5-week intervention and follow-up. participants will be enrolled in the group through the screening and plan to take regular diet, ogtt, high-fat diet, low-calorie diet and ketogenic diet within 5 weeks. the proteomics and metabolomics indicators of tear, plasma, and urine specimens will be measured at 5 time points at baseline, 30 minutes, 1 hour, 2 hours, and 3 hours for each diet. the correlation of proteomics and metabolomics indicators with classic laboratory parameters (bmi, hdl, ldl, cholesterol, triglyceride levels, and insulin resistance (homa-ir)) will be analyzed.


Eligibility criteria:
inclusion criteria: 1. healthy individuals aged 20-70 years, with a body mass index (bmi) of 18.5-40 kg/m². 2. no known chronic medical conditions. 3. willingness to comply with study requirements and adhere to the intervention protocol. exclusion criteria: 1. presence of significant medical conditions or chronic diseases. 2. diagnosis of diabetes mellitus or prediabetes. 3. triglyceride level ≥4 mmol/l. 4. blood pressure ≥160/100 mmhg or presence of malignant hypertension. 5. history of an eating disorder. 6. previous bariatric surgery. 7. severe gastrointestinal diseases. 8. history of diarrhea within the past two weeks. 9. special dietary requirements or known food allergies. 10. pregnancy or breastfeeding.
a pilot study of hp802-247 in dystrophic epidermolysis bullosa

Conditions: Dystrophic Epidermolysis Bullosa

Summary: this is a pilot study designed to see if hp802-247, an investigational treatment with living human skin cells, helps to heal blisters or wounds in subjects with dystrophic epidermolysis bullosa (deb). the durability of the skin in healed wounds treated with hp802-247 will also be assessed.


Eligibility criteria:
inclusion criteria: * written consent must be obtained from a parent or legally authorized representative. assent will be obtained according to local requirements. * subjects with a clinical diagnosis of deb with recurring blisters, ≥ 2 years of age at screening. subjects may be of either sex and of any race or skin type provided that their skin color, in the opinion of the investigator, will not interfere with the study assessments. * a parent or legally authorized representative must be willing and able to ensure subject is present for all required study visits. * a parent or legally authorized representative must be able to follow instructions. * have an open wound for ≤ 72 hours that: * is still open and has not scabbed or crusted over * has no dermatologic disease and/or condition in the treatment area (other than deb with recurring blisters), including active or recent infection (within 7 days) that may be exacerbated by treatment, require treatment with antibiotics / antifungals /antivirals, require a surgical intervention, or cause difficulty with examination * is ≥ 4 cm² and ≤ 48 cm2 in total area (open portion) * females of childbearing potential (defined as post-menarcheal as documented in the medical history) may participate in the study if they meet all of the following conditions: * they are not breast feeding; * they have a negative urine pregnancy test at week 1 period 1; * they agree to undertake scheduled urine pregnancy tests at week 1 for periods 1, 2, \& 3 and at study exit * they do not intend to become pregnant during the study; * they are using adequate birth control methods and they agree to continue using those methods for the duration of the study * a parent or legally authorized representative must be willing and able to ensure subject is present for all required study visits (for minor subjects) * a parent or legally authorized representative must be able to follow instructions (for minor subjects) exclusion criteria: * contraindications or hypersensitivity to the use of the test article, their components (e.g., aprotinin, fibrinogen), or substances used in the manufacture of the test article (e.g., penicillin, streptomycin, amphotericin b, bovine serum albumin). * therapy with another investigational agent within thirty (30) days of the screening visit, or during the study. * have uncontrolled intercurrent or chronic illness that, in the opinion of the investigator, would limit compliance with study requirements, represents a potential safety risk, or require treatment with an excluded drug/treatment. * the investigator or medical monitor may declare any subject ineligible for a valid medical reason.

Keywords: hp802-247 eb (epidermolysis bullosa)
a study of varenicline in the treatment of visceral sensation

Conditions: Irritable Bowel Syndrome

Summary: the purpose of this study is to evaluate the effect of varenicline on rectal sensation, based on ascending method of limits and on graded rapid phasic distensions in participants with non-constipation ibs and chronic abdominal pain.


Eligibility criteria:
inclusion criteria: 1. participants will be 18-70 years of age 2. irritable bowel syndrome with pain, but no constipation \[that is ibs-d (diarrhea), ibs-m (mixed), or ibs-u (unspecified)\] exclusion criteria: 1. diagnosis of moderate-severe depression as per hads\&gt;8 2. alcohol or illicit substance dependence or abuse in the past 12 months 3. dementia, unprovoked seizure history, seizure disorder 4. pregnancy (all women of childbearing potential will be required to have a negative pregnancy test prior to initiation, and will be on a highly effective method of contraception, as detailed in the consent form) 5. significant change or increase in antidepressant or pain medications within the last four weeks; significant change in primary treatment interventions for pain in the past four weeks 6. medically unstable 7. severe hepatic or renal impairment, such as baseline ast or alt \&gt;2.5 x upper normal limit or end-stage renal disease with estimated glomerular filtration rate or creatinine clearance \&lt;15 ml/min 8. concomitant use of strong cyp3a4 inhibitors and strong or moderate cyp3a4 inducers note: other protocol defined inclusion/exclusion criteria may apply. eligibility last updated 12/27/2024. questions regarding updates should be directed to the study team contact.

Keywords: ibs pain
clinical rescue protocol - 2

Conditions: Opioid-Related Disorders

Summary: the purpose of this study is to detect increasing medication dose results in heroin cessation for patients still using, to determine if decreasing medication dose in patients unable to tolerate medication dose increases retention, and to determine if blood levels of methadone or buprenorphine correlate with clinical response.


Eligibility criteria:
inclusion criteria: m/f ages 21-50. opiate dependence according to dsm-iv criteria. self-reported use within the last 30 days. agreeable to conditions of study and signed informed consent. exclusion criteria: psychiatric disorder that requires medication therapy. history of seizures. pregnant and/or nursing women. dependence on etoh or benzodiazepines or other sedative-hynotics. acute hepatitis. other medical conditions that deem participation to be unsafe.

Keywords: opioid
safety and efficacy of triple combination therapy in patients with primary open-angle glaucoma or ocular hypertension

Conditions: Glaucoma, Open-Angle; Ocular Hypertension

Summary: this study will evaluate the safety and efficacy of triple combination therapy compared with fixed combination brimonidine tartrate/timolol ophthalmic solution in patients with primary open-angle glaucoma or ocular hypertension.


Eligibility criteria:
inclusion criteria: * ocular hypertension or primary open-angle glaucoma in each eye * requires treatment with iop-lowering medication in both eyes exclusion criteria: * required chronic use of ocular medications during the study other than study medication * use of any corticosteroids within 30 days * history of any traumatic eye surgeries * cataract surgery in the past 6 months * anticipated wearing of contact lenses during the study